Technol, Maintenance (2nd Shift)

Edwards Lifesciences Gruppe; Salt Lake City (UT); On-site; USD 70,000 - 110,000; Full time

Job summary

Edwards Lifesciences Gruppe seeks a technical specialist to support Operations and Engineering. You will troubleshoot equipment, run feasibility studies, and lead validation projects to improve manufacturing processes. Collaboration with Quality and CAD teams is essential.

You will perform preventive maintenance, handle root cause analyses, and ensure compliant documentation. Strong communication and problem-solving skills are required in a GMP environment.

Qualifications

• Minimum HS diploma with 6 years related experience or an Associate's degree with 4 years related experience.
• Experience in manufacturing or medical device environments preferred.
• Strong problem solving, root cause analysis, and GDP/documentation practices.

Responsibilities

• Troubleshoot and perform maintenance to minimize downtime and maintain validation.
• Design, set-up and execute feasibility studies and tests for equipment and processes.
• Lead projects related to new equipment validation and investigations.
• Perform scheduled and unscheduled preventive maintenance on complex equipment.
• Collaborate with Quality on corrective actions, EWOs and ENCRs.
• Review and transfer validation documentation across systems and drawings.
• Use JDE, QMS, PLM to update documentation; coordinate with Engineering and CAD teams.
• Provide coaching to technicians and ensure on-time attendance and adherence to safety and quality guidelines.

Skills

Troubleshooting

Maintenance

Feasibility studies

Experimental design

Project leadership

Preventive maintenance

Documentation

CAD

JDE

QMS

PLM

GDP

MS Office

Education

HS Diploma with 6 years related experience

Associate's Degree with 4 years related experience

Tools

JDE

QMS

PLM

CAD

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Technol position is a unique career opportunity that could be your next step towards an exciting future.Provides technical and function-specific knowledge to support Operations and Engineering activities.Key Responsibilities:• Troubleshoot and recommend maintenance to limit downtime, to keep production on schedule, and to ensure ongoing validation compliance• Design, set-up and execute feasibility studies, experiments, and tests - both creating and following established protocols - to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review• Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework• Perform both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time• Check for failures in more complex equipment and processes, and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents• Collaborate with Quality in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs)• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval• Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems• Collaborate with Engineering and CAD/Designers to develop new basic tools• Provide coaching and guidance to technicians• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period• Other incidental duties (e.g. occasional photo copying or deliveries)Education and Experience:H.S. Diploma or equivalent 6 Years related experience Required orAssociate's Degree or equivalent 4 Years related experience Requiredprevious experience in manufacturing and/or medical device experience PreferredAdditional Skills:• Strong written and verbal communication, interpersonal, and relationship building skills• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)• Strong computer skills, including usage of MS Office Suite; and CAD if applicable• Full knowledge of validation and improvement of automated equipment• Ability to troubleshoot manufacturing equipment• Knowledge of material compatibility in the proposed use environment• Ability to understand the fundamentals of project management• Full knowledge of routine preventive maintenance of production equipment• Full knowledge electrical, mechanical, electronic, pneumatic, and controls• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment• Strict attention to detail• Must be able to work with other departments including formulating work instructions and providing guidance and training to lower-level employees with little to no direction• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.